Could someone please explain to me what the required content of a batch record is to comply with GMP, other than the reconciliation to the milligram between the inputs and the output + scrap ? Is a batch record the same as a “batch file” ? Are these not produced by the production system by printing out details of the production order ? If not, what content is written by hand ? Why are prices so high for this document ? Thanks for your time and attention.
You should have SOP for that preparation ,
it should be approved ,
it should meet Schedule-U and Schedule-m gidelines
Hand writing document chance is there , for modification